NCT06901024

Brief Summary

The 2018 update of the EULAR recommendations highlighted that exercise reduces pain and improves functionality in patients with hand OA. This study aimed to investigate the effects of neuromobilization, tendon gliding and robotic glove-assisted exercises on pain, grip strength and hand function in patients with hand osteoarthritis (OA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

March 23, 2025

Last Update Submit

March 27, 2025

Conditions

Keywords

OsteoarthritisNeuromobilizationTendon glidingRobotic Assistive Device

Outcome Measures

Primary Outcomes (4)

  • Australian-Canadian Hand Osteoarthritis Index

    The Australian-Canadian Hand Osteoarthritis Index (AUSCAN) is a self-report tool commonly used for the assessment of hand functionality in hand OA. The AUSCAN includes a total of 15 items measuring pain (5 items; 0 to 20 points), stiffness (1 item; 0 to 4 points), and function (9 items; 0 to 36 points) during the preceding 48 hours. Total possible scores range from 0 to 60 points

    8 weeks

  • Jebsen-Taylor Hand Function Test

    The Jebsen-Taylor Hand Function Test (JTHFT) is used to assess fine and gross motor hand function when performing activities of daily living (ADLs) and to measure the speed at which they perform the test tasks. The JTHFT is a valid and reliable tool and consists of 7 tasks, including writing, turning over cards, picking up objects, stacking checkers, simulated feeding, and moving light and heavy objects. Participants were asked to perform each task separately for each hand, and the time taken for each task was recorded using a stopwatch

    8 weeks

  • Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire

    The Quick-DASH short form consists of a total of 11 questions that ask about an individual's neurological symptoms, pain, sleep disturbances and their ability to work and perform certain activities in the previous week. Each item is assigned a score between 1 and 5: 1 (no difficulty), 2 (mild difficulty), 3 (moderate difficulty), 4 (severe difficulty), 5 (unable). Total possible scores range from 0 (no disability) to 100 (most severe disability). The total score is scaled between 0 (no disability) and 100 (maximum symptoms and disability)

    8 weeks

  • Pain Intensity

    The Visual Analog Scale (VAS) is a simple, self-administered tool. It consists of a 10-cm line, with the left end representing no pain and the right end representing worst possible pain. Individuals rate their pain intensity by marking a point on VAS, which is scored from 0 to 10.The point marked by the patient on the 10-cm line was measured using a ruler, and the corresponding distance in centimeters was recorded.

    8 weeks

Secondary Outcomes (2)

  • Static grip strength

    8 weeks

  • Perceived pain

    8 weeks

Study Arms (3)

Tendon gliding group

EXPERIMENTAL

The tendon gliding exercises were applied after conventional exercises.

Other: Tendon Gliding ExerciseOther: Conventional Exercises

Neuromobilization

EXPERIMENTAL

The neuromobilization were applied after conventional exercises.

Other: Neuromobilization ExerciseOther: Conventional Exercises

Robotic assisted exercises

EXPERIMENTAL

The robotic glove-assisted (RGA) exercise group performed passive movements for 60 minutes using soft robotic gloves (Masmel Health, Turkey), in combination with conventional exercises.

Other: Robotic Assitive ExerciseOther: Conventional Exercises

Interventions

Tendon gliding exercises were performed for both hands in a sequential manner, with 20 repetitions in 3 sets. The exercises started with fingers and wrist positioned in extension. Subsequent positions included the hook position, full fist position, MCP joint at 90° flexion with finger extension, and MCP and proximal interphalangeal (PIP) joints at 90° flexion positions, with a 5-second hold at each position. During the TG exercises, the hand and fingers are brought to five different positions

Tendon gliding group

The neuromobilization exercises included median, radial and ulnar nerve mobilizations. For median nerve mobilization, the patient's wrist was placed in extension, the shoulder in 90° abduction, the forearm in supination, the elbow extended, and the head positioned in lateral flexion toward the same side. For radial nerve mobilization, the wrist was initially placed in flexion and ulnar deviation, the forearm in pronation, with the elbow extended, and the head positioned in lateral flexion toward the same side. For ulnar nerve mobilization, the wrist was positioned in extension and radial deviation, the elbow fully flexed, the forearm in pronation, the shoulder in 90°abduction, and the head in lateral flexion toward the same side. The head was then moved into lateral flexion toward the opposite side while extending the elbow. The neuromobilization protocol was performed in 4 sets of 10 repetitions, with a 5-second hold for each movement.

Neuromobilization

The robotic glove set used in this study weighs 497 grams, powered by a battery weighing 170 grams that provides a 5 V voltage and 1 A current. Made from elastic fabric, the glove wraps around all fingers on both the dorsal and palmar sides. The palm section of the glove is hollow. The device features four Velcro straps: one at the wrist, one across the web space between the thumb and index finger, one between the second and third fingers, and one between the fourth and fifth fingers, securing the inner side of the wrist. The robotic glove facilitates passive joint movements through pneumatic air pressure. The device offers several benefits, including proprioceptive stimulation, visual input, increased functional independence, pain and edema reduction, enhanced lymphatic and blood circulation, improved coordination and hand dexterity, as well as increased grasp and compression strength.

Robotic assisted exercises

Wrist extensor exercise, wrist radial deviation exercise, and wrist flexor exercise were perfomed using a 1-kg dumbbell. Holding the 1-kg dumbbell against gravity for 10 seconds, with the shoulder flexed at 90°, elbow extended, and forearm in pronation position. Squeezing exercise with a green soft ball (Thera-Band; diameter: 5 cm); the ball was squeezed for 10 seconds, followed by relaxing. Pushing a blue Pilates ball (Thera-Band; diameter: 20 cm) against the wall with fingers in extension position. Squeezing a black Pilates ring (Thera-Band; diameter: 38 cm) with the fingers, while the MCP joints are in extension and the wrist in a neutral position.

NeuromobilizationRobotic assisted exercisesTendon gliding group

Eligibility Criteria

Age45 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients were diagnosed with primary hand OA by an orthopedics and traumatology specialist based on the ACR diagnostic criteria.
  • Aged 45 to 87 years

You may not qualify if:

  • Individuals were excluded from the study if they had a history of major psychiatric disorders, malignancies, systemic or rheumatologic diseases, severe hand trauma or surgery to the hand region within the past six months, prior intra-articular steroid or hyaluronic acid injections into the hand joints, collagen tissue disorders, peripheral vascular diseases, or a history of neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University, Department of Physiotherapy and Rehabilitation

Gaziantep, None Selected, 27144, Turkey (Türkiye)

Location

Related Publications (6)

  • Kloppenburg M, Kroon FP, Blanco FJ, Doherty M, Dziedzic KS, Greibrokk E, Haugen IK, Herrero-Beaumont G, Jonsson H, Kjeken I, Maheu E, Ramonda R, Ritt MJ, Smeets W, Smolen JS, Stamm TA, Szekanecz Z, Wittoek R, Carmona L. 2018 update of the EULAR recommendations for the management of hand osteoarthritis. Ann Rheum Dis. 2019 Jan;78(1):16-24. doi: 10.1136/annrheumdis-2018-213826. Epub 2018 Aug 28.

    PMID: 30154087BACKGROUND
  • Stoffer-Marx MA, Klinger M, Luschin S, Meriaux-Kratochvila S, Zettel-Tomenendal M, Nell-Duxneuner V, Zwerina J, Kjeken I, Hackl M, Ohlinger S, Woolf A, Redlich K, Smolen JS, Stamm TA. Functional consultation and exercises improve grip strength in osteoarthritis of the hand - a randomised controlled trial. Arthritis Res Ther. 2018 Nov 9;20(1):253. doi: 10.1186/s13075-018-1747-0.

    PMID: 30413191BACKGROUND
  • Horng YS, Hsieh SF, Tu YK, Lin MC, Horng YS, Wang JD. The comparative effectiveness of tendon and nerve gliding exercises in patients with carpal tunnel syndrome: a randomized trial. Am J Phys Med Rehabil. 2011 Jun;90(6):435-42. doi: 10.1097/PHM.0b013e318214eaaf.

    PMID: 21430512BACKGROUND
  • Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.

    PMID: 30175845BACKGROUND
  • Pedersini P, Valdes K, Cantero-Tellez R, Cleland JA, Bishop MD, Villafane JH. Effects of Neurodynamic Mobilizations on Pain Hypersensitivity in Patients With Hand Osteoarthritis Compared to Robotic Assisted Mobilization: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Feb;73(2):232-239. doi: 10.1002/acr.24103. Epub 2021 Jan 3.

    PMID: 31675184BACKGROUND
  • Villafane JH, Valdes K, Imperio G, Borboni A, Cantero-Tellez R, Galeri S, Negrini S. Neural manual vs. robotic assisted mobilization to improve motion and reduce pain hypersensitivity in hand osteoarthritis: study protocol for a randomized controlled trial. J Phys Ther Sci. 2017 May;29(5):801-806. doi: 10.1589/jpts.29.801. Epub 2017 May 16.

    PMID: 28603349BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Serkan Usgu

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All assessments were conducted by a single physiotherapist, who was blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients were divided into three groups: neuromobilization, tendon gliding, and robotic glove-assisted exercise group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physiotherapy Department

Study Record Dates

First Submitted

March 23, 2025

First Posted

March 28, 2025

Study Start

August 23, 2022

Primary Completion

November 3, 2023

Study Completion

January 10, 2024

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations